(227 days)
Not Found
No
The device description lists only mechanical components and there is no mention of AI, ML, image processing, or performance studies related to algorithmic performance.
No.
The device is described as an "access device" to assist in the treatment, not to directly treat the condition itself. Its components are instrumentation for creating a pathway, not for therapy delivery.
No
The device is described as an "Access Device" used for minimally invasive access to the spine for treatment purposes (decompression or discectomy), not for diagnosing conditions.
No
The device description lists multiple physical components (Blunt Trocar, Dilator Sheaths, Drill Bits, etc.), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed (trocars, dilators, sheaths, drill bits, cannula) are all instruments used for surgical access and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical instrument used within the human body.
N/A
Intended Use / Indications for Use
The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.
Product codes
HRX
Device Description
The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:
Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior portion of the lower spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy, Argus Medical Company Laparoscopic Discectomy Instrument System, The Nucleotome System and Probe Kits, Surgical dynamics Discography System, Sofamor Danek USA, Inc., Micro Endo Instruments
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
510(k) Summary of Safety and Effectiveness
In Accordance with CFR 807.92 (April 26, 1992), the following information is submitted:
| 1. | Name: | AXIAMED, Inc. |
|---|---|---|
| Address: | 5200 Willson Road | |
| Suite 150 | ||
| Edina, MN 55424 |
952 836-2660 Phone: 952 836-2661 Fax:
W. Allen Putnam Contact: Date of Summary Preparation: July 12, 2002
- Name of Device: AXIAMED Trans-Sacral Spinal Access Device 2. Generic Name: Rigid Endoscope and Instrument Set
-
- Predicate Devices:
Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy
Argus Medical Company Laparoscopic Discectomy Instrument System
The Nucleotome System and Probe Kits.
Surgical dynamics Discography System
Sofamor Danek USA, Inc., Micro Endo Instruments
- Device Description: 4.
The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:
Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet
Kc20457
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850.
SEP 2, 6 2002
Mr. W. Allen Putnam AXIAMED, Inc. 5200 Wilson Road, Suite 150 Edina, Minnesota 55424
Re: K020457
Trade Name: AXIAMED Trans-Sacral Spinal Access Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 12, 2002 Received: July 15, 2002
Dear Mr. Putnam:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. W. Allen Putnam
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Atypt Rhodes
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
020457
INDICATION FOR USE
The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.
Hyde Rhode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________